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Yoga for Pain and Opioid Dependence (Yoga)

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ClinicalTrials.gov Identifier: NCT01590251
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Addiction Other: Yoga Behavioral: Educational Counseling Phase 1 Phase 2

Detailed Description:

This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).

Specific Aims:

1) To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga for Pain and Opioid Dependence
Study Start Date : April 2012
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Yoga
Gentle yoga for chronic pain and opioid dependence
Other: Yoga
Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.
Active Comparator: Educational Counseling
Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.
Behavioral: Educational Counseling
One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.


Outcome Measures

Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 8 weeks ]
    Pain reduction will be measured by patient self-report using standard pain rating scales.

  2. Reduce illicit opioid use [ Time Frame: 8 weeks ]
    Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Prescription opioid addiction or heroin addiction
  • Moderate to severe chronic pain,
  • Understands English

Exclusion Criteria:

  • Current suicide or homicide risk
  • Life threatening or unstable medical condition
  • Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590251


Locations
United States, Connecticut
MRU
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Declan T Barry, Ph.D. Yale University
More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01590251     History of Changes
Other Study ID Numbers: 1111009292
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by Yale University:
Pain
Addiction
Buprenorphine
Counseling
Methadone
Yoga

Additional relevant MeSH terms:
Chronic Pain
Behavior, Addictive
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Compulsive Behavior
Impulsive Behavior
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents